Dr. Tetsuya Kusakabe is a Director of Office of Manufacturing Quality and Vigilance for Medical Devices from October 2021, and an International Coordination Officer from July 2020 at the Pharmaceuticals and Medical Devices Agency (PMDA). He graduated from Kyoto University and its Graduate School of Pharmaceutical Sciences, and received doctoral degree in 1999. He graduated from Harvard School of Public Health (HSPH) in 2004 and 2005. Prior to current positions, He has been working at the Ministry of Health, Labour and Welfare (MHLW) since 1996, and mainly involved in pharmaceutical administration including review and post-marketing safety. During this time, he was involved in research promotion at the Ministry of Education, Culture, Sports, Science and Technology (MEXT) from July 2000 to August 2002. He was a Visiting Scientist at U.S. Pharmacopeia (USP) working as a liaison between US and Japan from July 2011 to August 2012. He was a Review Director at PMDA, and engaged in reviewing bio-pharmaceuticals including cellular and tissue-based products and gene therapies from August 2012 to December 2013. He was a Professor at Osaka City University, Graduate School of Medicine, and was working for promoting clinical trials and medical innovation from July 2017 to July 2020.